TENORDATE

Arterial hypertension.

Pregnancy

The use of ATENOLOL/NIFEDIPINE BIOGARAN should be avoided as a precaution during the first trimester of pregnancy and may be considered if necessary during the second and third trimesters of pregnancy.

In case of treatment up to delivery, careful monitoring of the newborn during the first 3 to 5 days of life is recommended.

Atenolol

Animal studies have shown an absence of teratogenicity and other deleterious effects for the fetus after use of atenolol at therapeutic doses.

In humans, no teratogenic effect has been observed and no malformation has been reported in prospective studies conducted on beta-blockers.

In the newborn of a mother treated with atenolol, the beta-blocking action may persist for several days after birth, with the following clinical signs: bradycardia, respiratory distress or hypoglycemia, but most often the persistence of the effect is not clinically visible. However, heart failure requiring hospitalization in intensive care (see section 4.9) may occur due to reduction of compensatory cardiovascular reactions. In this case, fluid replacement solutions must be avoided (risk of OAP).

Nifedipine

Studies conducted in animals have highlighted the reprotoxic potential of nifedipine but the analysis of a limited number of exposed pregnancies has revealed no particular malformative effect.

During the 2nd and 3rd trimesters of pregnancy, the data are numerous and reassuring.

Cases of acute pulmonary edema have been observed with calcium channel blockers, including nifedipine, used as tocolytic agents during pregnancy (see section 4.8), particularly in case of multiple pregnancy (twins or more), with the intravenous route and/or concomitant use of beta-2 adrenergic receptor agonists.

Breastfeeding

The use of ATENOLOL/NIFEDIPINE BIOGARAN during breastfeeding must be accompanied by special attention.

Atenolol

Atenolol concentrations in breast milk are three times higher than in blood. During breastfeeding, only low levels of atenolol have been found in the child. Nevertheless, the appearance of beta-blocking properties in the child cannot be excluded.

Nifedipine

The passage of nifedipine into breast milk is very low.

Fertility

Reversible anomalies of the acrosomal reaction of spermatozoa that can lead to an alteration of fertilization have been reported in some patients under calcium antagonists.

It is unlikely that the use of ATENOLOL/NIFEDIPINE BIOGARAN has an influence on the ability to drive vehicles and use machines. However, it should be taken into consideration that sensations of dizziness or fatigue may occur.

The following adverse effects, mentioned by organ system class, have been reported with the following frequencies: very frequent (≥ 1/10); frequent (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).

* Frequency reported for the individual component atenolol.

** Frequency reported for the individual component nifedipine.

*** Cases have been reported during use as a tocolytic during pregnancy (see section 4.6).

Exceptional cases of extrapyramidal syndrome have been reported.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr